HIV policy and implementation: a national policy review and an implementation case study of a rural area of northern Malawi^†

† Affiliation where research conducted: The London School of Hygiene and Tropical Medicine.

Figures & data

Figure 1. Conceptual framework of policy and service factors influencing adult mortality across the diagnosis-to-treatment cascade. Reproduced from Church et al. (2015).

Figure 2. Karonga HDSS and location of health facilities. Copyright Malawi Epidemiology and Intervention Research Unit. Permission to reproduce has been given.

Table 1. Access to HIV testing and counseling.

Policy indicator	Year of WHO guideline	Malawi policy	Malawi practice: (i) Karonga HDSS facilities implementation, N = 6 offering HIV testing (number of facilities in parentheses) and (ii) insights from KIs
Service coverage and access factors
Free testing at public facilities	2003 implied	HTC, as a service of the Essential Health Package, should be provided free of charge in public-sector facilities and in stand-alone sites (Ministry of Health Malawi, 2006b). CHAM/private facilities liaise with DHO to get testing kits and they do not charge a service fee, although they might charge a consultation fee. If the DHO runs out and the private facility has to buy them elsewhere, there would be a charge to the patient.^a	Complies: In all 6 facilities, services reported as free for patients, including clinic registration fee, HIV test fee, equipment fees.
Provider-initiated testing and counseling (PITC) is standard for all clients including at ANC	2004	Health providers are asked to ascertain HIV status for all patients attending health services (PITC). Patients in ANC are especially encouraged for HTC, due to the Option B+ policy (Ministry of Health Malawi, 2011). The PITC concept was there at the beginning and started with ANC mothers.^a	Partial: All 5 facilities offering ANC, offer PITC. 4 out of 5 facilities offer PITC to OPD, TB, and STI/FP clients. However, 4 facilities noted it was “opt-in” rather than “opt-out” testing.
Testing targeted at high-risk groups (e.g., sex workers, men who have sex with men, injecting drug users)	2004	No specific policy on groups such as MSM, IDU, sex workers. The lack of policy on targeting MSM/sex workers contrasts with a long section on targeting testing to the deaf, dumb and visually impaired (Ministry of Health Malawi, 2006b)	Unclear: Testing services are “offered” (note, not “targeted”) to: sex workers (5), MSM (0), drug users (3), prisoners (1), truck drivers (3), factory/estate workers (1). Some moonlight testing takes place, where mobile clinics target sex workers/truck drivers in hot spots.^a
Parental consent not required for youth testing (<18)	2007	When any person aged 13+ is requesting HTC, they should be considered mature enough to give full and informed consent. Youth aged between 9 and 12 years and are sexually active should be regarded as mature minors and considered eligible to give consent for HTC. The HTC counselor should make an assessment of their readiness for HTC services. HTC for youth below 13 years of age should be done with the knowledge of their parents/guardians, unless this is not possible and the testing is for provision of treatment and care services.	Complies: Testing services are offered to schoolchildren in six facilities.
Quality of care factors
Anonymous HIV testing		No names recorded in HTC register. However, ART, TB, and ANC registers have names and HIV test results. For in-patients, the test result is documented in in-patient notes. All patient cards and clinic registers are the property of the Ministry of Health (MoH) and may only be kept at the respective facility or at the National Archives. They must be kept in a locked room and only accessed by clinic staff responsible for providing the respective service and by the national supervision team (Ministry of Health Malawi, 2011).	Not implemented: All facilities report they record patient HIV test data in registers/logbooks. One facility also records on patient-retained cards. The data collected are: sex, age/DOB, residence, name and test result.
Counselor counsels 15 clients/day max		Not specified	Unclear: 3 facilities reported there is no maximum. 2 facilities reported max 8. 1 facility reported max 10.
Periodic refresher training for counselors required	2001 onwards. No frequency	No clear guidelines. No new counselors are being recruited until refreshers have been done for all HTC counselors. This is because there were concerns over quality of service, so refresher trainings were prioritized.^a	Exceeds: 26 medical staff (doctors, clinical officers, nurses, trained counselors) provided HTC services. Out of these, 23 received formal training in HIV testing within the past 2 years.
Periodic quality control checks at testing sites required	2005. No frequency	Activities to maintain and strengthen quality of HTC services include an internal and external quality assurance for rapid HIV testing by laboratory technologist and proper documentation and dissemination of QA procedures and protocols to testing service providers, mentorship and supervision of services, client satisfaction surveys, mystery client surveys, awards/prizes/rewards, centers of HTC excellence etc. (Ministry of Health Malawi, 2006b)	Complies: Quality of care reviews/audits of HIV testing are conducted once every 3 months (3 facilities), once a month (2), and once a year (1).
Coordination of care and patient tracking factors
Negatives retest every 6–12 months	2007	Re-testing every 6–12 months is beneficial for individuals at higher risk of HIV infections, e.g., persons with a history of STI, sex workers and their clients, and sexual partners of PLHIV (Ministry of Health Malawi, 2009). The policy might change such that low-risk people (repeat HIV-) can leave a longer space between each test (economizing use of test resources).^a	Unclear: People who test HIV negative are advised to test again in 3 months (3 facilities), or test when they feel worried (3 facilities). It is unclear if the window period was misinterpreted as repeat testing, but if so, this is more frequent than policy. Testing when worried is ambiguous.
Repeat testing in 3rd trimester of pregnancy (if previously test negative)	2010	An HIV test should be provided on 1st ANC visit.^a It is also stated that HIV- women’s status should be considered unknown after 3 months window period (Ministry of Health Malawi, 2010). Therefore, if the woman attended ANC early in pregnancy, she would have repeat testing in the 3rd trimester.	Partial: All 5 facilities reported women get tested at first ANC visit for this pregnancy. Only 2 out of 5 facilities said the woman gets tested at their 3rd trimester visit.
Support to PLHIV factors
Individual as well as group pre-test counseling recommended	2003	Pre-test counseling is a requirement, either individually or group (Ministry of Health Malawi, 2006b, 2010). If done in a group there should be between 5 and 15 people in a group, and attempts should be made to ensure that the group is homogenous in relation to age and sex, and is culturally appropriate (Ministry of Health Malawi, 2009).	Complies: Pre-test counseling “always” given in 5 out of 6 facilities, and “usually” given in the 6th facility. All 6 sites do individual pre-test counseling. 5 out of 6 sites do group pre-test counseling.
Couple counseling encouraged	2004	Patients encouraged to attend HTC with their marital/sexual partner (Ministry of Health Malawi, 2006b, 2011). It was also planned that there should be at least 1 counselor at each testing site with specialist couple counseling skills (Ministry of Health Malawi, 2006b).	Complies: VCT for couples is offered in all 6 facilities.

CHAM=Christian Health Association of Malawi, DHO=District Health Office, MSM=Men who have sex with men, IDU=Injecting Drug User, TB=tuberculosis, OPD=Out patient department, STI=Sexually transmitted infection, DOB=Date of birth.

^aSource: Key informant interview.

Table 2. Access to HIV care and treatment.

Policy indicator	Year of WHO guideline	Malawi policy	Malawi practice (i) Karonga HDSS facilities implementation, N = 5 offering PMTCT and ART (number of facilities in parentheses) and (ii) insights from KIs.
Service coverage and access factors
Free PMTCT at public facilities	“Universal access”	PMTCT free at government facilities. Service-level agreements between MoH and CHAM makes it free of charge at CHAM.	Complies: All 5 facilities do not charge anything for PMTCT services (clinic registration, service fee, drugs, equipment). In practice, patients may have to pay a prescription fee at CHAM facilities, but they are not supposed to.^a
Free ART at public facilities	“Universal access”	ART to be provided free at point of delivery in public sector and CHAM to eligible persons (Ministry of Health Malawi, 2006a, 2006c). In private sector, ARV drugs will be subsidized, with patients paying roughly equivalent of US $4 (NAC Ministry of Health Malawi, 2005). Delivery of ART through private sector is to take load from public sector, thereby allowing it to concentrate on the free system.	Complies: All 5 facilities do not charge for HIV care and treatment services, including clinic registration, HIV care and treatment service fee, fees for drugs, equipment fees, laboratory tests.
PMTCT available at all ANC facilities	2010	In ANC, there should be a range of PMTCT activities including HTC for mother, siblings and partners, dispensing of ARVs for mother and baby, CD4 count and staging (Ministry of Health Malawi, 2010),	Complies: All 5 facilities providing ANC also provide PMTCT services.
Clinical officers, medical assistants and/or nurses initiate ART		All certified clinical PMTCT/ART providers are authorized to initiate, prescribe and dispense ART (doctors, clinical officers, medical assistants, registered nurses, nurse/midwife technicians). They need to have (a) attended a pre-service ART training module and passed the final exam, or (b) attended an ART training course recognized by MoH, Medical Council of Malawi and Nursing Council of Malawi and passed an exam (Ministry of Health Malawi, 2008).	Complies: All 5 facilities have nurses that can initiate. 3 facilities have clinical officers that can initiate. 1 facility has a medical assistant that can initiate.
All sites providing ART also initiate ART		All sites that provide ART also initiate ART. Facilities only provided with ARV drugs if formally assessed by MoH as ready to deliver ART. Readiness criteria include (a) plans for recruitment and follow-up of patients, (b) functioning CT services (c) dedicated room for ART delivery, equipped and has monitoring tools and copies of guidelines (d) trained staff and (e) secure storage for ARV drugs.	Complies: All 5 facilities providing ART also initiate ART.
Coordination of care and patient tracking factors
HIV-positive clients followed-up to ensure registration at treatment site	2004	No clear follow-up policy. Counselors should have a directory of HIV-related prevention, treatment, care and support services available for clients in catchment area. Patients’ HIV test results and names will be documented for such referrals (Ministry of Health Malawi, 2009).	Exceeds: Referral to HIV care and treatment services is documented in (a) patient notes (5 facilities), (b) recorded on a referral form (1), (c) referral letter with patient (3), register/logbook (2). Three facilities check if the HIV-positive patients register in HIV care/treatment services. Internal referrals (pre-ART, monitoring, ART initiation, ART resupply) are documented by register/logbook (3), referral letter (2), facility-held patient cards/notes (2), patient-retained cards (3).
Clear guidance on when HIV+ pregnant women be referred to ART clinic	2006	At the time of change to Option B+ (mid-2011), it was left to sites to decide whether to refer women to ART or to continue treatment in ANC, that is, no clear guidelines. In mid-2012, the MoH took stock of retention and found that the model of referral to ART did not work. New guidance stated that ART initiation and follow-up during pregnancy should be in ANC. After delivery, referral to ART still varies.	Unclear: Referral to ART clinics from ANC occurs in 3 facilities. Referral after delivery, and referral on the same day, occurs in 1 facility each, respectively. 4 facilities report that a health worker accompanies the woman to ART provider/unit. One facility reports sending the woman to ART provider/unit by herself. Many keep providing ART to women post-partum up to 6 months before referral to ART.^a
6 monthly CD4 testing in pre-ART with CD4<500		Repeat CD4 counts for patients over 5 years in pre-ART follow-up every 6 months. Move to 3-monthly CD4 counts if last count was less than 500. Stop CD4 monitoring once patient is eligible for ART (Ministry of Health Malawi, 2011).	No data in facility survey.
Medical management factors
WHO “Option B+” is standard (2012) (all HIV+ pregnant women initiate life-long ART)	2012	Option B+ since July 2011. TDF + 3TC (or FTC) + EFV (Ministry of Health Malawi, 2011).	Partial: 4 facilities reported that all HIV+ pregnant women initiate. Regimen is TDF/3TC/EFV, for life. 3 facilities provide treatment in same building as ANC but different room. 2 facilities provide in same facility as ANC but different building. All facilities provide treatment on same day as ANC services.
All patients with TB eligible for ART initiation	2009	Since the beginning of the program, Malawi made TB a stage 3 condition. It was not a WHO stage 3 condition, so Malawi went beyond WHO guidelines, and now WHO have followed.^a	See cell below.
Co-infected TB/HIV should initiate ART on same day or within 2 weeks of starting TB treatment	2013 (ASAP within 8 weeks)	Initiate ART (regimen 5A) within 14 days of diagnosis of active TB. TBT and ART can be started on the same day if patient is stable. (Ministry of Health Malawi, 2011). There was not clear guidance on timing prior to 2011. It was reasonable to start around the end of intensive phase of TB treatment (around 2 months) in order to avoid drug interactions.	Partial: 4 facilities say that TB medication and ART can be initiated together, when patients present with TB.
Initiate ART at WHO stage 3/4; or 1/2 with CD4<=350	2009	Initiate ART when WHO stage 1/2 and CD4 ≤ 350, or, WHO stage 3 or 4, regardless of CD4 count (Ministry of Health Malawi, 2011). Prior to 2011, it was a CD4 count of <250.	Partial: All 5 facilities said they’d initiate ART if clinical stage 3 or 4. 4 facilities said they’d initiate ART if CD4 count<350.
Initiate ART within 7 days of ART eligibility		Patients who are clinically stable should start ART no later than 7 days after being found eligible (Ministry of Health Malawi, 2011).	Unclear: 3 facilities said 2 separate visits to the clinic are required between ART eligibility and receiving ART drugs. 2 facilities said 1 visit is required. No time periods specified.
Lab tests not required to start ART (e.g., FBC, LFTS/RFTS)	Strongly recommended	Just clinical staging and CD4 testing, are needed (and a confirmatory HIV antibody test to rule out any possibility of mix-up of test results or fraudulent access to ART). FBC/LFTS/RFTS not required.	Complies: All 5 facilities reported that LFT, RFT, FBC are not required before a patient can initiate ART at this facility.
Adherence counseling not compulsory before ART initiation	Strongly recommended	All patients must receive (a) individual counseling at ART initiation and (b) group counseling 0–5 days before day of initiation. Option B+ women who start ART on same day are allowed to have counseling on a later day.	Partial: Before initiating ART, 4 facilities require at least 2 adherence counseling sessions, and one facility requires at least 1 adherence counseling session.

TDF = tenofovir, FTC = emtricitabine, EFV = efavirenz, FBC = Full blood count, QA = quality assurance.

^aSource: Key informant interview.

Table 3. Factors influencing retention in care.

Policy Indicator	WHO	Malawi policy	Malawi practice: (i) Karonga HDSS facilities implementation, N = 5, and (ii) insights from KIs^a
Service coverage and access factors
ART clinic does not have to include doctor or clinical officer		Minimum staff requirement includes 1 clinician (2006) (Ministry of Health Malawi, 2006a)	Partial: All 5 sites had at least one clinical officer or medical assistant
Quality of care factors
Periodic refresher training for ART staff required	2010	1-day ART classroom refresher training course to be taken once a year, followed by 1-day knowledge dissemination and best practice. To be organized at regional/zonal level (2006) (Ministry of Health Malawi, 2006b)	Not implemented: Out of a total of 43 staff, 15 had received formal medical/nursing training in HIV care and treatment in the past 2 years.
Periodic quality control checks at ART clinics required	2010	Team of experienced clinicians to go to every ART site every quarter, as supervision. They create a list of action points to be followed up. The form has a trigger to call a mentoring team, in case of problems. A certificate of excellence – motivation system – is awarded to “good” sites.^a	Complies: 4 out of 4 facilities said quality of care reviews / audits of HIV treatment services were conducted every 3 months. However, the nature of “quality of care review” is not known, nor whether it is as comprehensive as policy demands.
Coordination of care and patient tracking factors
Routine 6 monthly CD4 count monitoring on ART	Not a requisite	Routine scheduled CD4 monitoring of patients on ART is not supported by the national program (2011), to prioritize pre-ART follow up (Ministry of Health Malawi, 2011). Previously, it was recommended if capacity was there. But this led to limited capacity being used by a handful of sites with no tangible impact.	Partial: Two facilities conduct no CD4 tests once stabilized on ART. Two facilities report conducting them every 6 months. One facility does not do CD4 test routinely, but “done if requested”.
3 monthly drug supplies once stable on ART		Patients initiating 1st line ART reviewed after 2 weeks, then every month for first 6 months. Thereafter, stable and adherent patients can be given up to 3 months. In exceptional cases, up to 12 months of ARVs can be dispensed. Patients starting 2nd line ART must be seen every 4 weeks for first 6 months, thereafter, up to 2-month appointments. (2011) (Ministry of Health Malawi, 2011)	Partial: All 5 facilities said patients must return for refills every 2 months max, once they stabilize on ART
Pill counts at every visit		The emphasis was previously on the pill count (Ministry of Health Malawi, 2003). Now, the focus is on a formal active dialog (including an assessment and counseling). Ask “Have you had any problems taking your ARVs? Were there any days when you did not manage to take all your tablets at the right time?” Check “Next appointment date” on patient card to confirm patient is not late. (Ministry of Health Malawi, 2011)	Not implemented: All facilities check and count patients’ pillbox. Only two facilities also ask patients about pill-taking.
Home visits following signs of poor adherence		No policy regarding home visits. However, conduct follow-up group counseling and individual counseling if any sign of poor adherence. Give practical advice: (a) build ARVs into daily routine, (b) ask family or friends for reminders, (c) set a daily alarm on cell phones and (d) keep a “drug diary” and mark every tablet taken. (Ministry of Health Malawi, 2011)	Complies: For patients who present with low drug adherence, 1 facility insists on participation in support groups, and all 5 facilities provide psycho-social counseling.
Home visit or telephone contact for missed visits	2013	Patients late for ART appointment to be actively followed from the clinic (home visit, phone, guardian). Patients asked for consent for active follow-up at time of initiating ART (can withdraw consent any time). Prioritize patients on ART and HCC patients eligible to start ART. (2011) (Ministry of Health Malawi, 2011)	Partial: For patients that default, one facility does nothing, 3 facilities try to reach the patient by phone and 4 report to do home visits. For patients that are lost to follow up, 2 facilities do nothing, 2 facilities visit at home (1 missing).
Medical management factors
IPT for all HIV+ patients without active TB	2010	Give IPT to all HIV infected who are not on ART, regardless of clinical stage/CD4 count, who don’t have active TB. Start at enrollment for pre-ART follow-up and continue for as long as patient is in pre-ART follow-up. Stop IPT when ART is started (2011) (Ministry of Health Malawi, 2011).	Complies: All facilities offered IPT in pre-ART phase, and all currently had IPT in stock.
TB screening at every pre-ART and ART visit	2010	Yes. Screen all patients at every visit (pre-ART and ART) for signs of active TB using 4 standard questions (cough, fever, night sweats, weight loss/failure to thrive). If 1+ signs, thoroughly investigate further (2011) (Ministry of Health Malawi, 2011)	Partial: 3 out of 5 facilities screen for TB for all patients initiating ART. For those that don’t they would screen based on clinical symptoms of TB. Patients on ART are screened for TB in 4 out of 5 facilities.
WHO 1st line ART as standard	2010	D4T/3TC/NVP (Ministry of Health Malawi, 2011). But plans to switch.	Exceeds: All facilities providing TDF+3TC+EFV
At least four 1st line regimens choices in national programs	2006	There are 6 different 1st line regimens. 3 are used for initiating ART. All are fixed-dose combinations (only 1 type of tablet). Move patients with significant side effects to an alternative 1st line regimen. (2011) (Ministry of Health Malawi, 2011)	Partial: Variable. Number of different regimens in 4 of the facilities: 2, 2, 4, 6. Missing data for 5th.
Support to PLHIV factors
At least one adherence counseling conducted individually		All patients must receive individual counseling at ART initiation. In addition, patients should attend an ART group counseling session between 1–5 days before the day of ART initiation, or on same day as ART initiation. Patients must attend group counseling with named guardian (or treatment supporter). (2011) (Ministry of Health Malawi, 2011).	Complies: 4/5 fully adhere to Malawi policy. One facility just does individual counseling only.
All patients on ART referred to peer support groups		No MoH policy. It has not been proactive in pushing this. Left to the site, and their HSAs.	Exceeds: No question asked about referrals, but 3 facilities said there were support groups for PLWH in the community: 1 at another facility, 1 ran the support-group at the facility itself
Nutritional supplements for malnourished patients	2006	None. There used to be an HIV unit attempt at providing adult food interventions (plumpy-nut), but it was found to be expensive and it didn’t show a measureable impact. It was decided to treat the underlying condition (HIV) and this should address the malnutrition. So adult food supplementation was taken out of clinical guidelines.^a	Unclear: 3 facilities provide food-packages/nutritional support to patients. 2 facilities say that food-packages/nutritional support is available at another facility. But these were child nutrition programs.
All patients on ART referred to home-based care		Very little on home-based care, and not handled by HIV department. If anything, it is self-organized by individual sites, or NGOs.^a	Exceeds: All 5 facilities claim home-based care is provided either by them (2), another facility in the area (2), or at the community level (1)

^aSource: Key informant interview.

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